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Completed

NCT Number: NCT03141294

Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

Percutaneous dilatational tracheostomy (PDT), especially single-step dilatational tracheostomy (sd-PDT), is now frequently preferred to surgical tracheostomy. Occasionally, it needs a second dilation maneuver .Dissection of the deep cervical fascia during PDT, known as reformative PDT (re-PDT), may facilitate the procedure. This study was designed to compare re-PDT with sd-PDT in ICU patients

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Depression Respiratory Insufficiency Respiratory Tract Diseases

Age range

44 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affliated Hospital wiht Nanjing Medical University

Nanjing, Jiangsu, China

About this study

Percutaneous dilatational tracheostomy (PDT) is a popular airway management technique in the intensive care unit (ICU).Occasionally the first dilation may be challenging when using Ciaglia and colleagues' method, and a second dilation may be needed to insert the tracheostomy tube. In these circumstances, potentially life-threatening complications, such as hemorrhage and hypoxia, may arise. The investigators found the reasons for difficulty in achieving smooth dilation of the stoma.The investigators compared the traditional method with the improved method.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years;
  • requirement for long-term mechanical ventilation;
  • failure of weaning from mechanical ventilation.

Exclusion criteria

  • age <18 years;
  • pre-existing infection at the tracheostomy site;
  • pre-existing malignancy at the tracheostomy site;
  • difficulty in identifying the anatomic landmarks;
  • unstable cervical spine fracture;
  • international normalized ratio (INR) >2;
  • platelet count <50 000 mm3.

Treatment and study plan

reformative dilation technique

Procedure

reformative dilation technique was used when operating tracheostomy

Other names: reformative tracheostomy

Primary outcomes

  1. Force(newton)

    Time frame: Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)

    Force refers to the force needed to dilate the airway and measured by force gauge

Secondary outcomes

  1. Time(seconds)

    Time frame: Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime

    Time refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy: a Randomized Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
May 5, 2017
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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